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Arab Experts’ OfficeArab Union of Manufacturers of Pharmaceuticals and Medical Appliancesالعربية

Coverage you can inspect

Coverage and sources: what is available and what is missing?

A link or successful automated check does not establish complete country coverage or review of every document. This page separates available content, monitoring evidence and gaps.

Scientific coverage statement: 3 October 2026. Monitoring times below are read from the existing service when this page opens.

Scientific coverage across 11 fields

Guide counts do not measure specialist depth. Reviewing every existing calculator, study and legacy case, and documenting human reviewers, remains separate work that is not claimed complete.

Open the official authority directory for all 22 Arab countries — Documented authority gateways are available; automated monitoring is separately stated below.

Monitoring evidence for all 22 Arab countries

This uses the site’s existing monitoring-status service; opening the page does not start collection or publication. Additional discovery requires editorial review before publication.

Reading operational evidence…

CountryMapped sourceMonitoring modeLatest available resultLatest attempt · Dubai time
AlgeriaAuthority and official links
ANPP
Additional notice discoveryReading check status…—
BahrainAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
ComorosAuthority and official links
ANAMEV
Additional notice discoveryReading check status…—
DjiboutiAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
EgyptAuthority and official links
EDA
Core monitoringReading check status…—
IraqAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
JordanAuthority and official links
JFDA
Core monitoringReading check status…—
KuwaitAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
LebanonAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
LibyaAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
MauritaniaAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
MoroccoAuthority and official links
AMMPS
Additional notice discoveryReading check status…—
OmanAuthority and official links
OMAN_DSC
Additional notice discoveryReading check status…—
PalestineAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
QatarAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
Saudi ArabiaAuthority and official links
SFDA
Core monitoringReading check status…—
SomaliaAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
SudanAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
SyriaAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—
TunisiaAuthority and official links
ANMPS
Additional notice discoveryReading check status…—
United Arab EmiratesAuthority and official links
EDE
Additional notice discoveryReading check status…—
YemenAuthority and official linksNo documented mapping in this statementMonitoring evidence gap—

A monitoring evidence gap does not mean a country lacks a regulator or news. Unmapped sources returned by the service are reported in the status summary.

Source register for the new guides

Source pages and cited points were checked on 3 October 2026. Document status and effective date are distinct from that check date.

Primary sourceScopeVersion and status
EU GMP · Chapter 1European Union · pharmaceutical quality systemChapter 1, revision 3; operational since 31 January 2013
ICH Q9(R1) · EMAQuality risk management; check local adoptionEU effective from 26 July 2023; corrected-version page
EU GMP · Annex 1European Union · sterile manufacture2022 revision; fully applicable from 25 August 2024
EU GMP · Annex 15European Union · qualification and validation2015 revision; operational from 1 October 2015
EMA · Health-based exposure limitsExposure limits in shared facilitiesAdopted guidance; current first version published in 2014
FDA · Process ValidationUnited States · process validation lifecycleFinal guidance, January 2011
FDA · OOS investigationsUnited States · out-of-specification laboratory resultsRevision 1, May 2022; guidance recommendations are nonbinding
ICH Q2(R2) · EMAValidation of analytical proceduresEU effective from 14 June 2024
ICH Q14 · EMAAnalytical procedure development and maintenanceEU effective from 14 June 2024; page updated 24 February 2026
ICH Q1A(R2) · EMAStability of new drug substances and products within the guideline scopeCurrent effective version; EU effective 1 August 2003
ICH Q1 · consolidated stability draftProposed consolidated stability guidanceStep 2b draft; consultation closed, not final on the EMA page checked
FDA · Data integrity Q&AUnited States · CGMP data integrityFinal guidance, December 2018
ICH M13A · EMABE for immediate-release oral solid dosage forms delivering drug systemicallyEU effective from 25 January 2025
ICH · Common Technical DocumentDossier organisation; Module 1 is region-specificCTD structure page; submission requirements depend on the authority
EMA · Good pharmacovigilance practicesEuropean Union · pharmacovigilanceFinal-module index; Module III revision 2 effective from 10 September 2026
NLM · DailyMed: scope and limitationsUnited States · submitted, in-use labellingLiving database description; each label has its own date
EU · GDP guidelines 2013/C 343/01European Union · distribution of human medicinesPublished 23 November 2013; listed in EudraLex
IMDRF · Essential Principles N47International convergence principles; do not replace market requirementsN47 FINAL:2024, edition 2; 26 April 2024
ClinicalTrials.govSubmitted study records and resultsLiving registry; inspect each study’s update date
EQUATOR NetworkResearch reporting quality and transparencyResearch reporting guideline network
EMA · Biosimilar medicines overviewEuropean Union · biosimilar medicinesLiving overview; consult the relevant product guideline too
European Commission · HTAEuropean Union · health technology assessmentHTA portal and implementation documents
European Commission · EudraLex Volume 4European GMP and GDPVersion and applicability index; checked 3 October 2026

What still needs completion?

Start with the available working guides